Commission Directive 2008/60/EC of 17 June 2008 laying down specific purity criteria concerning sweeteners for use in foodstuffs (Codified version) (Text with EEA relevance)
2008/60/EC • 32008L0060
Legal Acts - L
- Inbound citations: 25
- •
- Cited paragraphs: 0
- •
- Outbound citations: 18
18.6.2008
EN
Official Journal of the European Union
L 158/17
COMMISSION DIRECTIVE 2008/60/EC
of 17 June 2008
laying down specific purity criteria concerning sweeteners for use in foodstuffs
(Text with EEA relevance)
(Codified version)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption (1), and in particular Article 3(3)(a) thereof,
Whereas:
(1)
Commission Directive 95/31/EC of 5 July 1995 laying down specific criteria of purity concerning sweeteners for use in foodstuffs (2) has been substantially amended several times (3). In the interest of clarity and rationality the said Directive should be codified.
(2)
It is necessary to establish purity criteria for all sweeteners mentioned in European Parliament and Council Directive 94/35/EC of 30 June 1994 on sweeteners for use in foodstuffs (4).
(3)
It is necessary to take into account the specifications and analytical techniques for sweeteners as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).
(4)
Food additives prepared by production methods or starting materials significantly different from those evaluated by the Scientific Committee for Food or different from those mentioned in this Directive should be submitted for safety evaluation by the European Food Safety Authority with emphasis on the purity criteria.
(5)
The measures provided for in this Directive are in line with the opinion of the Standing Committee on the Food Chain and Animal Health.
(6)
This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, Part B,
HAS ADOPTED THIS DIRECTIVE:
Article 1
The purity criteria referred to in Article 3(3)(a) of Directive 89/107/EEC for sweeteners mentioned in Directive 94/35/EC are set out in Annex I to this Directive.
Article 2
Directive 95/31/EC, as amended by the Directives listed in Annex II, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, Part B.
References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III.
Article 3
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Article 4
This Directive is addressed to the Member States.
Done at Brussels, 17 June 2008.
For the Commission
The President
José Manuel BARROSO
(1) OJ L 40, 11.2.1989, p. 27. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).
(2) OJ L 178, 28.7.1995, p. 1. Directive as last amended by Directive 2006/128/EC (OJ L 346, 9.12.2006, p. 6).
(3) See Annex II, Part A.
(4) OJ L 237, 10.9.1994, p. 3. Directive as last amended by Directive 2006/52/EC (OJ L 204, 26.7.2006, p. 10).
ANNEX I
SORBITOL
Synonyms
D-glucitol, D-sorbitol
Definition
Chemical name
D-glucitol
Einecs
200-061-5
Chemical formula
C6H14O6
Relative molecular mass
182,17
Assay
Content not less than 97 % of total glycitols and not less than 91 % of D-sorbitol on dry weight basis.
Glycitols are compounds with the structural formula CH2OH-(CHOH)n-CH2OH, where ‘n’ is an integer
Description
White hygroscopic powder, crystalline powder, flakes or granules having a sweet taste
Identification
A.
Solubility
Very soluble in water, slightly soluble in ethanol
B.
Melting range
88 to 102 °C
C.
Sorbitol monobenzylidene derivative
To 5 g of the sample add 7 ml of methanol, 1 ml of benzaldehyde and 1 ml of hydrochloric acid. Mix and shake in a mechanical shaker until crystals appear. Filter with the aid of suction, dissolve the crystals in 20 ml of boiling water containing 1 g of sodium bicarbonate, filter while hot, cool the filtrate, filter with suction, wash with 5 ml of methanol-water mixture (1 in 2) and dry in air. The crystals so obtained melt between 173 and 179 °C
Purity
Water content
Not more than 1 % (Karl Fischer method)
Sulphated ash
Not more than 0,1 % expressed on dry weight basis
Reducing sugars
Not more than 0,3 % expressed as glucose on dry weight basis
Total sugars
Not more than 1 % expressed as glucose on dry weight basis
Chlorides
Not more than 50 mg/kg expressed on dry weight basis
Sulphates
Not more than 100 mg/kg expressed on dry weight basis
Nickel
Not more than 2 mg/kg expressed on dry weight basis
Arsenic
Not more than 3 mg/kg expressed on dry weight basis
Lead
Not more than 1 mg/kg expressed on dry weight basis
Heavy metals
Not more than 10 mg/kg expressed as Pb on dry weight basis
SORBITOL SYRUP
Synonyms
D-glucitol syrup
Definition
Chemical name
Sorbitol syrup formed by hydrogenation of glucose syrup is composed of D-sorbitol, D-mannitol and hydrogenated saccharides.
The part of the product which is not D-sorbitol is composed mainly of hydrogenated oligosaccharides formed by the hydrogenation of glucose syrup used as raw material (in which case the syrup is non-crystallising) or mannitol. Minor quantities of glycitols where n ≤ 4 may be present. Glycitols are compounds with the structural formula CH2OH-(CHOH)n-CH2OH, where ‘n’ is an integer
Einecs
270-337-8
Assay
Content not less than 69 % total solids and not less than 50 % of D-sorbitol on the anhydrous basis
Description
Clear colourless and sweet-tasting aqueous solution
Identification
A.
Solubility
Miscible with water, with glycerol, and with propane-1,2-diol
B.
Melting range
To 5 g of the sample add 7 ml of methanol, 1 ml of benzaldehyde and 1 ml of hydrochloric acid. Mix and shake in a mechanical shaker until crystals appear. Filter with the aid of suction, dissolve the crystals in 20 ml of boiling water containing 1 g of sodium bicarbonate, filter while hot. Cool the filtrate filter with suction, wash with 5 ml of methanol-water mixture (1 in 2) and dry in air. The crystals so obtained melt between 173 and 179 °C
Purity
Water content
Not more than 31 % (Karl Fischer method)
Sulphated ash
Not more than 0,1 % expressed on dry weight basis
Reducing sugars
Not more than 0,3 % expressed as glucose on dry weight basis
Chlorides
Not more than 50 mg/kg expressed on dry weight basis
Sulphates
Not more than 100 mg/kg expressed on dry weight basis
Nickel
Not more than 2 mg/kg expressed on dry weight basis
Arsenic
Not more than 3 mg/kg expressed on dry weight basis
Lead
Not more than 1 mg/kg expressed on dry weight basis
Heavy metals
Not more than 10 mg/kg expressed as Pb on dry weight basis
MANNITOL
MANNITOL
Synonyms
D-mannitol
Definition
Manufactured by catalytic hydrogenation of carbohydrate solutions containing glucose and/or fructose
Chemical name
D-mannitol
Einecs
200-711-8
Chemical formula
C6H14O6
Molecular weight
182,2
Assay
Content not less than 96,0 % D-mannitol and not more than 102 % on the dried basis
Description
White, odourless, crystalline powder
Identification
A.
Solubility
Soluble in water, very slightly soluble in ethanol, practically insoluble in ether
B.
Melting range
Between 164 and 169 °C
C.
Thin layer chromatography
Passes test
D.
Specific rotation
[α] 20 D: + 23 ° to + 25 ° (borate solution)
E.
pH
Between 5 and 8
Add 0,5 ml of a saturated solution of potassium chloride to 10 ml of a 10 % w/v solution of the sample, then measure the pH
Purity
Loss on drying
Not more than 0,3 % (105 °C, four hours)
Reducing sugars
Not more than 0,3 % (as glucose)
Total sugars
Not more than 1 % (as glucose)
Sulphated ash
Not more than 0,1 %
Chlorides
Not more than 70 mg/kg
Sulphate
Not more than 100 mg/kg
Nickel
Not more than 2 mg/kg
Lead
Not more than 1 mg/kg
MANNITOL MANUFACTURED BY FERMENTATION
Synonyms
D-mannitol
Definition
Manufactured by discontinuous fermentation under aerobic conditions using a conventional strain of the yeast Zygosaccharomyces rouxii
Chemical name
D-mannitol
Einecs
200-711-8
Chemical formula
C6H14O6
Molecular weight
182,2
Assay
Not less than 99 % on the dried basis
Description
White, odourless crystalline powder
Identification
A.
Solubility
Soluble in water, very slightly soluble in ethanol, practically insoluble in ether
B.
Melting range
Between 164 and 169 °C
C.
Thin layer chromatography
Passes test
D.
Specific rotation
[α] 20 D: + 23 ° to + 25 ° (borate solution)
E.
pH
Between 5 and 8
Add 0,5 ml of a saturated solution of potassium chloride to 10 ml of a 10 % w/v solution of the sample, then measure the pH
Purity
Arabitol
Not more than 0,3 %
Loss on drying
Not more than 0,3 % (105 °C, four hours)
Reducing sugars
Not more than 0,3 % (as glucose)
Total sugars
Not more than 1 % (as glucose)
Sulphated ash
Not more than 0,1 %
Chlorides
Not more than 70 mg/kg
Sulphate
Not more than 100 mg/kg
Lead
Not more than 1 mg/kg
Aerobic mesophilic bacteria
Not more than 103/g
Coliforms
Absent in 10 g
Salmonella
Absent in 10 g
E. Coli
Absent in 10 g
Staphylococcus aureus
Absent in 10 g
Pseudomonas aeruginosa
Absent in 10 g
Moulds
Not more than 100/g
Yeasts
Not more than 100/g
ACESULFAME K
Synonyms
Acesulfame potassium, potassium salt of 3,4-dihydro-6-methyl-1,2,3-oxathiazin-4-one,2,2-dioxide
Definition
Chemical name
6-methyl-1,2,3-oxathiazin-4(3H)-one-2,2-dioxide potassium salt
Einecs
259-715-3
Chemical formula
C4H4KNO4S
Molecular weight
201,24
Assay
Content not less than 99 % of C4H4KNO4S on the anhydrous basis
Description
Odourless, white, crystalline powder. Approximately 200 times as sweet as sucrose
Identification
A.
Solubility
Very soluble in water, very slightly soluble in ethanol
B.
Ultraviolet absorption
Maximum 227 ± 2 nm for a solution of 10 mg in 1 000 ml of water
C.
Positive test for potassium
Passes test (test the residue obtained by igniting 2 g of the sample)
D.
Precipitation test
Add a few drops of a 10 % solution of sodium cobalt nitrite to a solution of 0,2 g of the sample in 2 ml of acetic acid and 2 ml of water. A yellow precipitate is produced
Purity
Loss on drying
Not more than 1 % (105 °C, two hours)
Organic impurities
Passes test for 20 mg/kg of UV active components
Fluoride
Not more than 3 mg/kg
Lead
Not more than 1 mg/kg
ASPARTAME
Synonyms
Aspartyl phenylalanine methyl ester
Definition
Chemical name
N-L-α-(Aspartyl-L-phenylalanine-1-methyl ester, 3-amino-N-(α-carbomethoxy-phenethyl)-succinamic acid-N-methyl ester
Einecs
245-261-3
Chemical formula
C14H18N2O5
Relative molecular mass
294,31
Assay
Not less than 98 % and not more than 102 % of C14H18N2O5 on the anhydrous basis
Description
White, odourless, crystalline powder having a sweet taste. Approximately 200 times as sweet as sucrose
Identification
Solubility
Slightly soluble in water and in ethanol
Purity
Loss on drying
Not more than 4,5 % (105 °C, four hours)
Sulphated ash
Not more than 0,2 % expressed on dry weight basis
pH
Between 4,5 and 6,0 (1 in 125 solution)
Transmittance
The transmittance of a 1 % solution in 2N hydrochloric acid, determined in a 1-cm cell at 430 nm with a suitable spectrophotometer, using 2N hydrochloric acid as a reference, is not less than 0,95, equivalent to an absorbance of not more than approximately 0,022
Specific rotation
[α]D 20: + 14,5 to + 16,5 °
Determine in a 4 in 100/15 N formic acid solution within 30 minutes after preparation of the sample solution
Arsenic
Not more than 3 mg/kg expressed on dry weight basis
Lead
Not more than 1 mg/kg expressed on dry weight basis
Heavy metals
Not more than 10 mg/kg expressed as Pb on dry weight basis
5-Benzyl-3,6-dioxo-2-piperazineacetic acid
Not more than 1,5 % expressed on dry weight basis
CYCLAMIC ACID AND ITS Na AND Ca SALTS
CYCLAMIC ACID
Synonyms
Cyclohexylsulphamic acid, cyclamate
Definition
Chemical name
Cyclohexanesulphamic acid, cyclohexylaminosulphonic acid
Einecs
202-898-1
Chemical formula
C6H13NO3S
Relative molecular mass
179,24
Assay
Cyclohexylsulphamic acid contains not less than 98 % and not more than the equivalent of 102 % of C6H13NO3S, calculated on the anhydrous basis
Description
A practically colourless, white crystalline powder with a sweet-sour taste. Approximately 40 times as sweet as sucrose
Identification
A.
Solubility
Soluble in water and in ethanol
B.
Precipitation test
Acidify a 2 % solution with hydrochloric acid, add 1 ml of an approximately molar solution of barium chloride in water and filter if any haze or precipitate forms. To the clear solution add 1 ml of a 10 % solution of sodium nitrite. A white precipitate forms.
Purity
Loss on drying
Not more than 1 % (105 °C, one hour)
Selenium
Not more than 30 mg/kg expressed as selenium on dry weight basis
Lead
Not more than 1 mg/kg expressed on dry weight basis
Heavy metals
Not more than 10 mg/kg expressed as Pb on dry weight basis
Arsenic
Not more than 3 mg/kg expressed on dry weight basis
Cyclohexylamine
Not more than 10 mg/kg expressed on dry weight basis
Dicyclohexylamine
Not more than 1 mg/kg expressed on dry weight basis
Aniline
Not more than 1 mg/kg expressed on dry weight basis
SODIUM CYCLAMATE
Synonyms
Cyclamate, sodium salt of cyclamic acid
Definition
Chemical name
Sodium cyclohexanesulphamate, sodium cyclohexylsulphamate
Einecs
205-348-9
Chemical formula
C6H12NNaO3S and the dihydrate form C6H12NNaO3S·2H2O
Relative molecular mass
201,22 calculated on the anhydrous form
237,22 calculated on the hydrated form
Assay
Not less than 98 % and not more than 102 % on the dried basis
Dihydrate form: not less than 84 % on the dried basis
Description
White, odourless crystals or crystalline powder. Approximately 30 times as sweet as sucrose
Identification
Solubility
Soluble in water, practically insoluble in ethanol
Purity
Loss on drying
Not more than 1 % (105 °C, one hour)
Not more than 15,2 % (105 °C, two hours) for the dihydrate form
Selenium
Not more than 30 mg/kg expressed as selenium on dry weight basis
Arsenic
Not more than 3 mg/kg expressed on dry weight basis
Lead
Not more than 1 mg/kg expressed on dry weight basis
Heavy metals
Not more than 10 mg/kg expressed as Pb on dry weight basis
Cyclohexylamine
Not more than 10 mg/kg expressed on dry weight basis
Dicyclohexylamine
Not more than 1 mg/kg expressed on dry weight basis
Aniline
Not more than 1 mg/kg expressed on dry weight basis
CALCIUM CYCLAMATE
Synonyms
Cyclamate, calcium salt of cyclamic acid
Definition
Chemical name
Calcium cyclohexanesulphamate, calcium cyclohexylsulphamate
Einecs
205-349-4
Chemical formula
C12H24CaN2O6S2·2H2O
Relative molecular mass
432,57
Assay
Not less than 98 % and not more than 101 % on the dried basis
Description
White, colourless crystals or crystalline powder. Approximately 30 times as sweet as sucrose
Identification
Solubility
Soluble in water, sparingly soluble in ethanol
Purity
Loss on drying
Not more than 1 % (105 °C, one hour)
Not more than 8,5 % (140 °C, four hours) for the dihydrate form
Selenium
Not more than 30 mg/kg expressed as selenium on dry weight basis
Arsenic
Not more than 3 mg/kg expressed on dry weight basis
Lead
Not more than 1 mg/kg expressed on dry weight basis
Heavy metals
Not more than 10 mg/kg expressed as Pb on dry weight basis
Cyclohexylamine
Not more than 10 mg/kg expressed on dry weight basis
Dicyclohexylamine
Not more than 1 mg/kg expressed on dry weight basis
Aniline
Not more than 1 mg/kg expressed on dry weight basis
ISOMALT
Synonyms
Hydrogenated isomaltulose, hydrogenated palatinose.
Definition
Chemical name
Isomalt is a mixture of hydrogenated mono- and disaccharides whose principal components are the disaccharides:
6-O-α-D-Glucopyranosyl-D-sorbitol (1,6-GPS) and
1-O-α-D-Glucopyranosyl-D-mannitol dihydrate (1,1-GPM)
Chemical formula
6-O-α-D-Glucopyranosyl-D-sorbitol: C12H24O11
1-O-α-D-Glucopyranosyl-D-mannitol dihydrate: C12H24O11.2H2O
Relative molecular mass
6-O-α-D-Glucopyranosyl-D-sorbitol: 344,32
1-O-α-D-Glucopyranosyl-D-mannitol dihydrate: 380,32
Assay
Content not less than 98 % of hydrogenated mono- and disaccharides and not less than 86 % of the mixture of 6-O-α-D-Glucopyranosyl-D-sorbitol and 1-O-α-D-Glucopyranosyl-D-mannitol dihydrate determined on the anhydrous basis.
Description
Odourless, white, slightly hygroscopic, crystalline mass.
Identification
A.
Solubility
Soluble in water, very slightly soluble in ethanol.
B.
Thin layer chromatography
Examine by thin layer chromatography using a plate coated with an approximately 0,2 mm layer of chromatographic silica gel. The principal spots in the chromatogram are those of 1,1-GPM and 1,6-GPS.
Purity
Water content
Not more than 7 % (Karl Fischer Method)
Sulphated ash
Not more than 0,05 % expressed on dry weight basis
D-Mannitol
Not more than 3 %
D-Sorbitol
Not more than 6 %
Reducing sugars
Not more than 0,3 % expressed as glucose on dry weight basis
Nickel
Not more than 2 mg/kg expressed on dry weight basis
Arsenic
Not more than 3 mg/kg expressed on dry weight basis
Lead
Not more than 1 mg/kg expressed on dry weight basis
Heavy metals (as Pb)
Not more than 10 mg/kg expressed on dry weight basis.
SACCHARIN AND ITS Na, K AND Ca SALTS
SACCHARIN
Definition
Chemical name
3-Oxo-2,3-dihydrobenzo(d)isothiazol-1,1-dioxide
Einecs
201-321-0
Chemical formula
C7H5NO3S
Relative molecular mass
183,18
Assay
Not less than 99 % and not more than 101 % of C7H5NO3S on the anhydrous basis
Description
White crystals or a white crystalline powder, odourless or with a faint, aromatic odour, having a sweet taste even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose
Identification
Solubility
Slightly soluble in water, soluble in basic solutions, sparingly soluble in ethanol
Purity
Loss on drying
Not more than 1 % (105 °C, two hours)
Melting range
226 to 230 °C
Sulphated ash
Not more than 0,2 % expressed on dry weight basis
Benzoic and salicylic acid
To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears
o-Toluenesulphonamide
Not more than 10 mg/kg expressed on dry weight basis
p-Toluenesulphonamide
Not more than 10 mg/kg expressed on dry weight basis
Benzoic acid p-sulphonamide
Not more than 25 mg/kg expressed on dry weight basis
Readily carbonisable substances
Absent
Arsenic
Not more than 3 mg/kg expressed on dry weight basis
Selenium
Not more than 30 mg/kg expressed on dry weight basis
Lead
Not more than 1 mg/kg expressed on dry weight basis
SODIUM SACCHARIN
Synonyms
Saccharin, sodium salt of saccharin
Definition
Chemical name
Sodium o-benzosulphimide, sodium salt of 2,3-dihydro-3-oxobenzisosulphonazole, oxobenzisosulphonazole, 1,2-benzisothiazolin-3-one-1, 1-dioxide sodium salt dihydrate
Einecs
204-886-1
Chemical formula
C7H4NNaO3S·2H2O
Relative molecular mass
241,19
Assay
Not less than 99 % and not more than 101 % of C7H4NNaO3S on the anhydrous basis
Description
White crystals or a white crystalline efflorescent powder, odourless or with a faint odour, having an intensely sweet taste, even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose in dilute solutions
Identification
Solubility
Freely soluble in water, sparingly soluble in ethanol
Purity
Loss on drying
Not more than 15 % (120 °C, four hours)
Benzoic and salicylic acid
To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears
o-Toluenesulphonamide
Not more than 10 mg/kg expressed on dry weight basis
p-Toluenesulphonamide
Not more than 10 mg/kg expressed on dry weight basis
Benzoic acid p-sulphonamide
Not more than 25 mg/kg expressed on dry weight basis
Readily carbonisable substances
Absent
Arsenic
Not more than 3 mg/kg expressed on dry weight basis
Selenium
Not more than 30 mg/kg expressed on dry weight basis
Lead
Not more than 1 mg/kg expressed on dry weight basis
CALCIUM SACCHARIN
Synonyms
Saccharin, calcium salt of saccharin
Definition
Chemical name
Calcium o-benzosulphimide, calcium salt of 2,3-dihydro-3-oxobenzisosulphonazole, 1,2-benzisothiazolin-3-one-1,1-dioxide calcium salt hydrate (2:7)
Einecs
229-349-9
Chemical formula
H
Relative molecular mass
467,48
Assay
Not less than 95 % of C14H8CaN2O6S2 on the anhydrous basis
Description
White crystals or a white crystalline powder, odourless or with a faint odour, having an intensely sweet taste, even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose in dilute solutions
Identification
Solubility
Freely soluble in water, soluble in ethanol
Purity
Loss on drying
Not more than 13,5 % (120 °C, four hours)
Benzoic and salicylic acid
To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears
o-Toluenesulphonamide
Not more than 10 mg/kg expressed on dry weight basis
p-Toluenesulphonamide
Not more than 10 mg/kg expressed on dry weight basis
Benzoic acid p-sulphonamide
Not more than 25 mg/kg expressed on dry weight basis
Readily carbonisable substances
Absent
Arsenic
Not more than 3 mg/kg expressed on dry weight basis
Selenium
Not more than 30 mg/kg expressed on dry weight basis
Lead
Not more than 1 mg/kg expressed on dry weight basis
POTASSIUM SACCHARIN
Synonyms
Saccharin, potassium salt of saccharin
Definition
Chemical name
Potassium o-benzosulphimide, potassium salt of 2,3-dihydro-3-oxobenzisosulphonazole, potassium salt of 1,2-benzisothiazolin-3-one-1,1-dioxide monohydrate
Einecs
Chemical formula
C7H4KNO3S·H2O
Relative molecular mass
239,77
Assay
Not less than 99 % and not more than 101 % of C7H4KNO3S on the anhydrous basis
Description
White crystals or a white crystalline powder, odourless or with a faint odour, having an intensely sweet taste, even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose
Identification
Solubility
Freely soluble in water, sparingly soluble in ethanol
Purity
Loss on drying
Not more than 8 % (120 °C, four hours)
Benzoic and salicylic acid
To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears
o-Toluenesulphonamide
Not more than 10 mg/kg expressed on dry weight basis
p-Toluenesulphonamide
Not more than 10 mg/kg expressed on dry weight basis
Benzoic acid p-sulphonamide
Not more than 25 mg/kg expressed on dry weight basis
Readily carbonisable substances
Absent
Arsenic
Not more than 3 mg/kg expressed on dry weight basis
Selenium
Not more than 30 mg/kg expressed on dry weight basis
Lead
Not more than 1 mg/kg expressed on dry weight basis
SUCRALOSE
Synonyms
4,1′,6′-Trichlorogalactosucrose
Definition
Chemical name
1,6-Dichloro-1,6-dideoxy-β-D-fructofuranosyl-4-chloro-4-deoxy-α-D-galactopyranoside
Einecs
259-952-2
Chemical formula
C12H19Cl3O8
Molecular weight
397,64
Assay
Content not less than 98 % and not more than 102 % C12H19Cl3O8 calculated on an anhydrous basis.
Description
White to off-white, practically odourless, crystalline powder.
Identification
A.
Solubility
Freely soluble in water, methanol and ethanol
Slightly soluble in ethyl acetate
B.
Infrared absorption
The infrared spectrum of a potassium bromide dispersion of the sample exhibits relative maxima at similar wave numbers as those shown in the reference spectrum obtained using a sucralose reference standard.
C.
Thin layer chromatography
The main spot in the test solution has the same Rf value as that of the main spot of standard solution A referred to in the test for other chlorinated disaccharides. This standard solution is obtained by dissolving 1,0g of sucralose reference standard in 10 ml of methanol.
D.
Specific rotation
[α] 20 D + 84,0 ° to + 87,5 ° calculated on the anhydrous basis
(10 % w/v solution)
Purity
Water
Not more than 2,0 % (Karl Fischer method)
Sulphated ash
Not more than 0,7 %
Other chlorinated disaccharides
Not more than 0,5 %
Chlorinated monosaccharides
Not more than 0,1 %
Triphenylphosphine oxide
Not more than 150 mg/kg
Methanol
Not more than 0,1 %
Lead
Not more than 1 mg/kg
THAUMATIN
Synonyms
Definition
Chemical name
Thaumatin is obtained by aqueous extraction (pH 2,5 to 4) of the arils of the fruit of the natural strain of Thaumatococcus daniellii (Benth) and consists essentially of the proteins thaumatin I and thaumatin II together with minor amounts of plant constituents derived from the source material
Einecs
258-822-2
Chemical formula
Polypeptide of 207 amino acids
Relative molecular mass
Thaumatin I 22209
Thaumatin II 22293
Assay
Not less than 16 % nitrogen on the dried basis equivalent to not less than 94 % proteins (N × 5,8)
Description
Odourless, cream-coloured powder with an intensely sweet taste. Approximately 2 000 to 3 000 times as sweet as sucrose
Identification
Solubility
Very soluble in water, insoluble in acetone
Purity
Loss on drying
Not more than 9 % (105 °C to constant weight)
Carbohydrates
Not more than 3 % expressed on dry weight basis
Sulphated ash
Not more than 2 % expressed on dry weight basis
Aluminium
Not more than 100 mg/kg expressed on dry weight basis
Arsenic
Not more than 3 mg/kg expressed on dry weight basis
Lead
3 mg/kg expressed on dry weight basis
Microbiological criteria
Total aerobic microbial count: Max 1 000/g E. Coli: absent in 1 g
NEOHESPERIDINE DIHYDROCHALCONE
Synonyms
Neohesperidin dihydrochalcone, NHDC, hesperetin dihydrochalcone-4′-β-neohesperidoside, neohesperidin DC
Definition
Chemical name
2-O-α-L-rhamnopyranosyl-4′-β-D-glucopyranosyl hesperetin dihydrochalcone; obtained by catalytic hydrogenation of neohesperidin
Einecs
243-978-6
Chemical formula
C28H36O15
Relative molecular mass
612,6
Assay
Content not less than 96 % on the dried basis
Description
Off-white, odourless, crystalline powder having a characteristic, intensive sweet taste. Approximately between 1 000 and 1 800 times as sweet as sucrose
Identification
A.
Solubility
Freely soluble in hot water, very slightly soluble in cold water, practically insoluble in ether and benzene
B.
Ultraviolet absorption maximum
282 to 283 nm for a solution of 2 mg in 100 ml methanol
C.
Neu's test
Dissolve about 10 mg of neohesperidine DC in 1 ml methanol, add 1 ml of a 1 % 2-aminoethyl diphenyl borate methanolic solution. A bright yellow colour is produced
Purity
Loss on drying
Not more than 11 % (105 °C, three hours)
Sulphated ash
Not more than 0,2 % expressed on dry weight basis
Arsenic
Not more than 3 mg/kg expressed on dry weight basis
Lead
Not more than 2 mg/kg expressed on dry weight basis
Heavy metals
Not more than 10 mg/kg expressed as Pb on dry weight basis
SALT OF ASPARTAME-ACESULFAME
Synonyms
Aspartame-acesulfame, Aspartame-acesulfame salt
Definition
The salt is prepared by heating an approximately 2:1 ratio (w/w) of aspartame and acesulfame K in solution at acidic pH and allowing crystallisation to occur. The potassium and moisture are eliminated. The product is more stable than aspartame alone.
Chemical name
6-Methyl-1,2,3-oxathiazine-4(3H)-one-2,2-dioxide salt of L-phenylalanyl-2-methyl-L-α-aspartic acid
Chemical formula
C18H23O9N3S
Molecular weight
457,46
Assay
63,0 % to 66,0 % aspartame (dry basis) and 34,0 % to 37,0 % acesulfame (acid form on a dry basis)
Description
A white, odourless, crystalline powder.
Identification
A.
Solubility
Sparingly soluble water; slightly soluble in ethanol
B.
Transmittance
The transmittance of a 1 % solution in water determined in a 1 cm cell at 430 nm with a suitable spectrophotometer using water as a reference, is not less than 0,95, equivalent to an absorbance of not more than approximately 0,022.
C.
Specific rotation
[α] 20 D + 14,5 ° to + 16,5 °
Determine at a concentration of 6,2 g in 100 ml formic acid (15N) within 30 min of preparation of the solution. Divide the calculated specific rotation by 0,646 to correct for the aspartame content of the salt of aspartame-acesulfame
Purity
Loss on drying
Not more than 0,5 % (105 °C, four hours)
5-Benzyl-3,6-dioxo-2-piper-azineacetic acid
Not more than 0,5 %
Lead
Not more than 1 mg/kg
MALTITOL
Synonyms
D-Maltitol, hydrogenated maltose
Definition
Chemical name
(α)-D-Glucopyranosyl-1,4-D-glucitol
Einecs
209-567-0
Chemical formula
C12H24O11
Relative molecular mass
344,31
Assay
Content not less than 98 % D-maltitol C12H24O11 on the anhydrous basis
Description
Sweet tasting, white crystalline powder
Identification
A.
Solubility
Very soluble in water, slightly soluble in ethanol
B.
Melting range
148 to 151 °C
C.
Specific rotation
[α]D 20 = + 105,5 ° to + 108,5 ° (5 % w/v solution)
Purity
Water content
Not more than 1 % (Karl Fischer method)
Sulphated ash
Not more than 0,1 % expressed on dry weight basis
Reducing sugars
Not more than 0,1 % expressed as glucose on dry weight basis
Chlorides
Not more than 50 mg/kg expressed on dry weight basis
Sulphates
Not more than 100 mg/kg expressed on dry weight basis
Nickel
Not more than 2 mg/kg expressed on dry weight basis
Arsenic
Not more than 3 mg/kg expressed on dry weight basis
Lead
Not more than 1 mg/kg expressed on dry weight basis
MALTITOL SYRUP
Synonyms
Hydrogenated high-maltose-glucose syrup, hydrogenated glucose syrup
Definition
A mixture consisting of mainly maltitol with sorbitol and hydrogenated oligo- and polysaccharides. It is manufactured by the catalytic hydrogenation of high maltose-content glucose syrup or by the hydrogenation of its individual components followed by blending. The article of commerce is supplied both as a syrup and as a solid product.
Assay
Content not less than 99 % of total hydrogenated saccharides on the anhydrous basis and not less than 50 % of maltitol on the anhydrous basis
Description
Colourless and odourless, clear viscous liquids or white crystalline masses
Identification
A.
Solubility
Very soluble in water, slightly soluble in ethanol
B.
Thin layer chromatography
Passes test
Purity
Water
Not more than 31 % (Karl Fischer)
Reducing sugars
Not more than 0,3 % (as glucose)
Sulphated ash
Not more than 0,1 %
Chlorides
Not more than 50 mg/kg
Sulphate
Not more than 100 mg/kg
Nickel
Not more than 2 mg/kg
Lead
Not more than 1 mg/kg
LACTITOL
Synonyms
Lactit, lactositol, lactobiosit
Definition
Chemical name
4-O-β-D-Galactopyranosyl-D-glucitol
Einecs
209-566-5
Chemical formula
C12H24O11
Relative molecular mass
344,32
Assay
Not less than 95 % on the dry weight basis
Description
Sweet-tasting crystalline powders or colourless solutions. Crystalline products occur in anhydrous, monohydrate and dihydrate forms
Identification
A.
Solubility
Very soluble in water
B.
Specific rotation
[α]D 20 = + 13 ° to + 16 ° calculated on the anhydrous basis (10 % w/v aqueous solution)
Purity
Water content
Crystalline products; not more than 10,5 % (Karl Fischer method)
Other polyols
Not more than 2,5 % on the anhydrous basis
Reducing sugars
Not more than 0,2 % expressed as glucose on dry weight basis
Chlorides
Not more than 100 mg/kg expressed on dry weight basis
Sulphates
Not more than 200 mg/kg expressed on dry weight basis
Sulphated ash
Not more than 0,1 % expressed on dry weight basis
Nickel
Not more than 2 mg/kg expressed on dry weight basis
Arsenic
Not more than 3 mg/kg expressed on dry weight basis
Lead
Not more than 1 mg/kg expressed on dry weight basis
XYLITOL
Synonyms
Xylitol
Definition
Chemical name
D-xylitol
Einecs
201-788-0
Chemical formula
C5H12O5
Relative molecular mass
152,15
Assay
Not less than 98,5 % as xylitol on the anhydrous basis
Description
White, crystalline powder, practically odourless with a very sweet taste
Identification
A.
Solubility
Very soluble in water, sparingly soluble in ethanol
B.
Melting range
92 to 96 °C
C.
pH
5 to 7 (10 % w/v aqueous solution)
Purity
Loss on drying
Not more than 0,5 %. Dry 0,5 g of sample in a vacuum over phosphorus at 60 °C for four hours
Sulphated ash
Not more than 0,1 % expressed on dry weight basis
Reducing sugars
Not more than 0,2 % expressed as glucose on dry weight basis
Other polyhydric alcohols
Not more than 1 % expressed on dry weight basis
Nickel
Not more than 2 mg/kg expressed on dry weight basis
Arsenic
Not more than 3 mg/kg expressed on dry weight basis
Lead
Not more than 1 mg/kg expressed on dry weight basis
Heavy metals
Not more than 10 mg/kg expressed as Pb on dry weight basis
Chlorides
Not more than 100 mg/kg expressed on dry weight basis
Sulphates
Not more than 200 mg/kg expressed on dry weight basis
ERYTHRITOL
Synonyms
Meso-erythritol, tetrahydroxybutane, erythrite
Definition
Obtained by fermentation of carbohydrate source by safe and suitable food grade osmophilic yeasts such as Moniliella pollinis or Trichosporonoides megachilensis, followed by purification and drying
Chemical name
1,2,3,4-Butanetetrol
Einecs
205-737-3
Chemical formula
C4H10O4
Molecular weight
122,12
Assay
Not less than 99 % after drying
Description
White, odourless, non-hygroscopic, heat-stable crystals with a sweetness of approximately 60-80 % that of sucrose.
Identification
A.
Solubility
Freely soluble in water, slightly soluble in ethanol, insoluble in diethyl ether.
B.
Melting range
119-123 °C
Purity
Loss on drying
Not more than 0,2 % (70 °C, six hours, in a vacuum desiccator)
Sulphated ash
Not more than 0,1 %
Reducing substances
Not more than 0,3 % expressed as D-glucose
Ribitol and glycerol
Not more than 0,1 %
Lead
Not more than 0,5 mg/kg
ANNEX II
PART A
Repealed Directive with list of its successive amendments
(referred to in Article 2)
Commission Directive 95/31/EC
(OJ L 178, 28.7.1995, p. 1)
Commission Directive 98/66/EC
(OJ L 257, 19.9.1998, p. 35)
Commission Directive 2000/51/EC
(OJ L 198, 4.8.2000, p. 41)
Commission Directive 2001/52/EC
(OJ L 190, 12.7.2001, p. 18)
Commission Directive 2004/46/EC
(OJ L 114, 21.4.2004, p. 15)
Commission Directive 2006/128/EC
(OJ L 346, 9.12.2006, p. 6)
PART B
List of time-limits for transposition into national law
(referred to in Article 2)
Directive
Time-limit for transposition
95/31/EC
1 July 1996 (1)
98/66/EC
1 July 1999
2000/51/EC
30 June 2001
2001/52/EC
30 June 2002
2004/46/EC
1 April 2005
2006/128/EC
15 February 2008
(1) According to Article 2(2) of Directive 95/31/EC, products put on the market or labelled before 1 July 1996 which do not comply with this Directive may be marketed until stocks are exhausted.
ANNEX III
Correlation table
Directive 95/31/EC
This Directive
Article 1(1)
Article 1
Article 1(2)
—
Article 2
—
—
Article 2
Article 3
Article 3
Article 4
Article 4
Annex
Annex I
—
Annex II
—
Annex III